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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Integrated Fixation, Lumbar
510(k) Number K260810
Device Name Anteralign LS coverplate
Applicant
Tyber Medical, LLC
83 S. Commerce Way, Suite 310
Bethlehem,  PA  18017
Applicant Contact Rajan Kaur
Correspondent
Tyber Medical, LLC
83 S. Commerce Way, Suite 310
Bethlehem,  PA  18017
Correspondent Contact Rajan Kaur
Regulation Number888.3080
Classification Product Code
OVD  
Date Received03/12/2026
Decision Date 06/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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